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Hydrocortisone - Generic Drug Details
What are the generic drug sources for hydrocortisone and what is the scope of freedom to operate?
Hydrocortisone
is the generic ingredient in seventy-five branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Medicis, Paddock Llc, Ani Pharms, Teva Pharms, Healthpoint, Pharmacia And Upjohn, Baker Norton, Marnel Pharms, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Perrigo Co, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Mission Pharma, Pfizer, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Vintage, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Sebela Ireland Ltd, Akorn, Bel Mar, Fera Pharms, Colgate, Genus, Glenmark Generics, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Cosette, Glenmark Pharms Ltd, Perrigo Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are sixty-seven drug master file entries for hydrocortisone. Thirty-one suppliers are listed for this compound.
Summary for hydrocortisone
| US Patents: | 2 |
| Tradenames: | 75 |
| Applicants: | 110 |
| NDAs: | 254 |
| Drug Master File Entries: | 67 |
| Suppliers / Packagers: | 31 |
| Bulk Api Vendors: | 94 |
| Clinical Trials: | 346 |
| Patent Applications: | 7,169 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for hydrocortisone |
| Drug Sales Revenues: | Drug sales revenues for hydrocortisone |
| DailyMed Link: | hydrocortisone at DailyMed |
Recent Clinical Trials for hydrocortisone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lumedix | N/A |
| Beckman Coulter, Inc. | N/A |
| Versailles Saint-Quentin-en-Yvelines University | N/A |
Pharmacology for hydrocortisone
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for hydrocortisone
US Patents and Regulatory Information for hydrocortisone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ambix | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 086271-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Schering | OTOBIONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 061816-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacia And Upjohn | NEO-CORTEF | hydrocortisone acetate; neomycin sulfate | CREAM;TOPICAL | 061049-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Strides Pharma | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 207029-003 | Apr 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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